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APAC Data Use Agreement Amendment - Limited or Custom Data Set Instructions Use this form for amendments or renewals of Limited or Custom All Payer All Claims (APAC) data request applications that have been submitted, approved and have an executed Data Use Agreement. If you have not received an Application Number and wish to make changes to your submitted application, please contact [email protected]. The Application Number and Applicant Name must match the information from the original application and Data Use Agreement. Please list changes in the appropriate section and provide sufficient details to allow staff to evaluate the request. All changes supersede the original application and Data Use Agreement. Completed form should be sent to: [email protected] Or Office of Health Analytics - APAC 421 SW Oak Street, Suite 850 Portland, OR 97204 If you have questions while completing this application, please follow these steps: 1. Visit the APAC website for more information about the APAC Reporting Program at http://www.oregon.gov/oha/analytics/Pages/All-Payer-All-Claims.aspx 2. Visit the APAC Data Request page for more information about the data request process at http://www.oregon.gov/oha/analytics/Pages/APAC-Data-Requests.aspx 3. Review the APAC Frequently Asked Questions to determine if your question has been answered there. 4. If you still have questions, a. Direct questions about APAC or this application to: [email protected] b. Direct data privacy questions to: [email protected] c. Direct data security questions to: [email protected] OFFICE OF HEALTH ANALYTICS All Payer All Claims Data Reporting Program Kate Brown, Governor 421 SW Oak Street, Suite 850 Portland, OR 97204 Website: www.oregon.gov/oha/analytics

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Page 1: State of Oregon : Oregon.gov Home Page : State of Oregon - … Page Docs... · 2017. 8. 2. · Please list changes in the appropriate section and provide sufficient details to

APAC Data Use Agreement Amendment - Limited or Custom Data Set

Instructions Use this form for amendments or renewals of Limited or Custom All Payer All Claims (APAC) data requestapplications that have been submitted, approved and have an executed Data Use Agreement. If you have not received an Application Number and wish to make changes to your submitted application, please contact [email protected].

The Application Number and Applicant Name must match the information from the original application and Data Use Agreement. Please list changes in the appropriate section and provide sufficient details to allow staff to evaluate the request. All changes supersede the original application and Data Use Agreement.

Completed form should be sent to:

[email protected] Or Office of Health Analytics - APAC 421 SW Oak Street, Suite 850 Portland, OR 97204

If you have questions while completing this application, please follow these steps:

1. Visit the APAC website for more information about the APAC Reporting Program athttp://www.oregon.gov/oha/analytics/Pages/All-Payer-All-Claims.aspx

2. Visit the APAC Data Request page for more information about the data request process athttp://www.oregon.gov/oha/analytics/Pages/APAC-Data-Requests.aspx

3. Review the APAC Frequently Asked Questions to determine if your question has been answeredthere.

4. If you still have questions,a. Direct questions about APAC or this application to: [email protected]. Direct data privacy questions to: [email protected]. Direct data security questions to: [email protected]

OFFICE OF HEALTH ANALYTICS All Payer All Claims Data Reporting Program

Kate Brown, Governor

421 SW Oak Street, Suite 850 Portland, OR 97204

Website: www.oregon.gov/oha/analytics

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SECTION 1: PROJECT INFORMATION

1.1 Contact Information: Please provide the project contact information below.

Applicant name (must be the same applicant of original project):

Application Number (example: APACYYYYXXXX or XXXX_description_of_project):

Organization:

Address:

City: State: Zip:

Phone:

Email:

Original Application Date:

Is this an amendment (changes to the application—including revising project staff, request of additional data not specified in original application, etc.) or a renewal of an expiring Data Use Agreement or Institutional Review Board approval without any changes to the original application? Please choose only one. An amendment will also renew the Data Use Agreement.

Amendment ☐ Please continue to Section 2

Renewal ☐ Please continue to Section 3

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2.2 List any staff that will no longer be working on the project:

Name: Role:

Name: Role:

Name: Role:

Name: Role:

Name: Role:

2.3 What is the reason for the amendment?

2.4 Did the original application include an Institutional Review Board review and approval?

Yes ☐ No ☐

(If no, proceed to question 2.7)

2.5 Is the amendment within the scope of the original IRB approval?

Yes ☐ No ☐

If yes, please explain:

If no, requestor must submit new application, not an amendment.

2.6 Is an amended IRB approval attached? (An amended IRB approval is required for any

amendments to the scope of the project.)

Yes ☐ No ☐

Date amended IRB approval expires:

2.7 Are you requesting additional data files, data elements, or years of data?

Yes ☐ No ☐

(If yes, proceed to question 2.8-11. If no, skip question 2.8-11.)

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2.8 Limited Data Sets: In the table below, indicate which additional data file(s) you are requesting. Refer to the Data Element Workbook for more information about the data elements included in each Limited data set. Please note: OHA will only provide the minimum necessary required data for the project at hand. In other words, you will only receive those data elements that you request and adequately justify.

a. Are you requesting a Limited data set?

☐ Yes ☐ NoIf yes, please complete parts b and c below.

b. In the table below, indicate which Limited data file(s) you are requesting (refer toQuestion 2.11 for the cost of each file).

Payer

All Payers1

Medicaid Medicare

Advantage Commercial Insurance

OEBB/ PEBB

Medicare FFS2

Data File

Episodes of Care3 ☐ ☐ ☐ ☐ ☐ ☐

All Medical Claims4 ☐ ☐ ☐ ☐ ☐ ☐

Hospital Inpatient Claims ☐ ☐ ☐ ☐ ☐ ☐

Emergency Department Claims ☐ ☐ ☐ ☐ ☐ ☐

Ambulatory Surgery Claims ☐ ☐ ☐ ☐ ☐ ☐

Ambulatory Outpatient Claims ☐ ☐ ☐ ☐ ☐ ☐

All Pharmacy Claims5 ☐ ☐ ☐ ☐ ☐ ☐

c. Please indicate the year(s) requested for the data files selected above.

☐ 2011 ☐ 2012 ☐ 2013 ☐ 2014 ☐ 2015

1 All Payers includes Medicaid, Medicare Advantage, and Commercial Insurance (including OEBB/PEBB). 2 Medicare FFS data will only be given to projects in which OHA is funding and directing. Projects requesting Medicare FFS data will also need to be approved by requester’s Institutional Review Board. 3 Episodes of Care file contains all medical claims, all pharmacy claims, and fields from the Medical Episode Grouper (MEG). MEG is a proprietary grouping algorithm that creates episodes that describe a patient’s complete course of care for a single illness or condition. If requesting Episodes of Care file, no other data file is needed. 4 All Medical Claims file includes hospital inpatient, emergency department, ambulatory surgery and ambulatory outpatient claims, and other hospital treatment settings. If requesting all medical claims, you do not need to request these other data sets. 5 All Pharmacy Claims file contains only pharmacy claims.

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2.9 Custom Data Sets: Refer to the Data Elements Collected by APAC section of the Data User Guide for a list of data elements available. Please note: OHA will only provide the minimum necessary data for the project. In other words, you will only receive those data elements that you request and adequately justify. a. Are you requesting a Custom data set?

☐ Yes ☐ No

2.10 Data Element Workbook: For both Limited and Custom data set amendment requests, please complete the Data Element Workbook according to the instructions on the “Instructions” tab and attach it to this amendment.

☐ Data Element Workbook completed and attached, including justifications for each element requested and payers tab completed.

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2.11 Cost of Data: If requesting additional data from the Limited data set, please calculate the cost below. (This table should match the files/years selected in Questions 2.8b and 2.8c.) Please include payment with the application. Checks should be made to Oregon Health Authority and will not be cashed until application is approved. If requesting a Custom data set, an invoice will be sent if/when OHA approves request.

Payers

All Payers

Medicaid Medicare

Advantage

Commercial Insurance

OEBB/ PEBB

Medicare FFS

Dat

a Fi

le

Episodes of Care ☐ $3,000 ☐ $1,000 ☐ $1,000 ☐ $1,000 ☐ $1,000 ☐ $1,000

All Medical Claims ☐ $1,500 ☐ $500 ☐ $500 ☐ $500 ☐ $500 ☐ $500

Hospital Inpatient Claims ☐ $375 ☐ $125 ☐ $125 ☐ $125 ☐ $125 ☐ $125

Emergency Department Claims

☐ $375 ☐ $125 ☐ $125 ☐ $125 ☐ $125 ☐ $125

Ambulatory Surgery Claims

☐ $375 ☐ $125 ☐ $125 ☐ $125 ☐ $125 ☐ $125

Ambulatory Outpatient Claims

☐ $375 ☐ $125 ☐ $125 ☐ $125 ☐ $125 ☐ $125

All Pharmacy Claims ☐ $1,500 ☐ $500 ☐ $500 ☐ $500 ☐ $500 ☐ $500

a. Total each column

b. Add column totals

c. Enter number of years ofdata requested (Q2.8.c)

d. Multiply rows b and c

e. OHA Production Cost $560

f. Add rows d and e for TotalPayment

☐ Check box if payment is not included because Custom data set is requested.

☐ Check box if payment is not included for another reason. Please explain.

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SECTION 3: RENEWAL

Please check the appropriate boxes. This section is for those renewing an existing Data Use Agreement or Institutional Review Board approval that is about to expire without requesting further changes to the content of the original application.

OHA Data Use Agreement Renewal (for applicants in which the OHA Data Use Agreement is about to expire)

By checking the above box, applicant hereby attests that the project shall continue to be conducted as specified in the Data Use Agreement referenced in Section 1 and the project has been renewed by Principal Investigator’s Institutional Review Board, if applicable. (If original application required Institutional Review Board approval, an amended Institutional Review Board approval is required for renewal outside the original Institutional Review Board approval timeframe.)

Amended Institutional Review Board approval documentation is attached. ☐

Original Institutional Review Board approval is still valid for more than 3 months. ☐

Original application did not include Institutional Review Board approval. ☐

Institutional Review Board Approval Renewal (for applicants in which the OHA Data Use Agreement is still valid, but the original Institutional Review Board approval is about to expire)

By checking the above box, applicant hereby attests that the project shall continue to be conducted as specified in the Data Use Agreement referenced in Section 1 and the project has been renewed by applicant’s Institutional Review Board. (Amended Institutional Review Board approval is required for renewal outside the original Institutional Review Board approval timeframe.)

Amended Institutional Review Board documentation is attached. ☐

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See Filters tab for sample filters.

Data Element Name Years Requested Filters Applied Justification Notes

Member Months

personkey Unique person identifier 2012-2015 Needed as a linkage variable

patid Encrypted patient ID 2012-2015 Needed as a linkage variable

effdate Effective date 2012-2015 Needed to create enrollment periods for patients/beneficiaries

termdate Termination date 2012-2015 Needed to create enrollment periods for patients/beneficiaries

payer APAC Payer 2012-2015 Needed to partition member months into payer categories

prod Product code 2012-2015 Needed to separate members enrolled in HMO plans

medflag Medical coverage flag 2012-2015 Needed to identify whether medical services are covered (as opposed to just not used)

rxflag Pharmacy coverage flag 2012-2015 Needed to identify whether pharmacy services are covered (as opposed to just not used)

pebb PEBB flag 2012-2015 Plan type vairable needed to construct comparison groups

oebb OEBB flag 2012-2015 Plan type vairable needed to construct comparison groups

Age Member age (years) 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

gender Member gender 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Race Member race 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Ethn Member ethnicity 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Lang Primary spoken language 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Zip Member ZIP code of residence 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

county Member county of residence 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Msa MSA 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

year Calendar year 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

tpa_or_pbm_duplicate_mm Third party administrator or pharma 2012-2015 Needed to deduplicate member months

yob Member year of birth 2012-2015 Needed to precisely calculate age as required for specific quality measures

medicaid Type of Medicaid coverage (FFS, M 2012-2015 Custom field created by OHA using CCO ID variable; in combination with Payer and Prod variables, allows partition of member months into payer categories

medicare Type of Medicare coverage (MED, A 2012-2015 Custom field created by OHA using A.PAYER_LOB; in combination with Payer and Prod variables, allows partition of member months into payer categories

Dual Indicator for dual coverage (enrolled 2012-2015 Custom field created by OHA; in combination with Medicaid and Medicare variables, allows identification of dual eligible members for subgroup analysis

NonElg Eligible for Medicaid 2012-2015 Custom field created by OHA; in combination with Payer and Prod, allows identification of Medicaid members

SNP Indicator for enrollment in Duals Sp 2012-2015 Custom field created by OHA; in combination with Payer and Prod, allows identification of members in dual eligible special needs plans for subgroup analysis

Payer ID Unique identifier for each payer that 2012-2015 Needed to filter out certain payers identified by OHA as having problematic data

Carrier name Name of health insurance carrier as 2012-2015 Needed to filter out certain payers identified by OHA as having problematic data

2012-2015

All Medical 2012-2015

clmid Claim ID 2012-2015 Needed to de-duplicate claim lines

line Claim line 2012-2015 Needed to de-duplicate claim lines

clmstatus Claim status 2012-2015 Needed to de-duplicate claim lines

cob COB status

2012-2015

Y/N flag Needed to adjust for individuals with coverage from

multiple plans

paytype Payer type

2012-2015

Needed to provide additional granularity on differences in

patient populations and utilization across payers

prod Product code

2012-2015

Needed for analysis separating individuals covered under

HMO plans vs. individuals covered in PPO plans

payer APAC Payer 2012-2015 Needed to account for different payment rates

medflag Medical coverage flag

2012-2015

Y/N flag Needed to identify individuals with medical coverage

only, rx coverage only, or both (e.g., to exclude

individuals with medical coverage only in analyses of total

cost)

rxflag Pharmacy coverage flag

2012-2015

Y/N flag See line 13; allows for inclusion/exclusion criteria (e.g.,

individuals without rx coverage could be included in

analyses of hospitalizations in order to improve power but

excluded from analyses of total cost due to missing data)

pebb PEBB flag

2012-2015

0/1 flag Plan type vairable needed to construct comparison

groups

oebb OEBB flag

2012-2015

0/1 flag Plan type vairable needed to construct comparison

groups

patid Encrypted patient ID 2012-2015 Needed to de-duplicate claim lines

personkey Unique person identifier 2012-2015 Needed to de-duplicate claim lines

gender Gender

2012-2015

F, M, or U Needed as an independent variable in statistical models

to account for person-level demographic effects

Specify filters for each element

requested, if applicable.

Justify why each element requested is necessary.

Indicate data elements requested. Use extract

column name for elements from limited data sets.

Use data element format AA### for elements from

the Data Elements Collected by APAC section of the

APAC Data User Guide.

Indicate the name of each element

requested.

You may request any of the data elements APAC collects, including any data elements in the limited data sets, and any listed in the Data Elements Collected by APAC section of the APAC Data User Guide.

Complete columns A-E for all data elements requested. Provide any optional notes in column F. Direct identifiers such as patient name, address, or exact dates of service are only released under special

circumstances that comply with HIPAA requirements, and may require specific approvals such as Institutional Review Board (IRB) approval and patient consent, and review by the Department of Justice.

Custom Data Set

Please Note: Only complete this tab if you are requesting a custom data set instead of a limited data set.

Provide any notes about the data elements requested, if applicable.

OHA recommends certain data elements for all requests depending on claim type, as they are necessary to properly interpret duplicate claim lines. These elements are pre-populated in the table below.

Requesters should still fill out columns C and D for these elements. If you do not wish to receive a pre-populated element, delete the entire row.

If requesting a custom data set, you must also complete the Payers tab.

See Instructions tab for further instructions and information about pre-populated elements.

Indicate year(s) for

each element

requested.

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Data Element Name Years Requested Filters Applied Justification Notes

yob Birth year

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

race Race

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

ethn Ethnicity

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

lang Primary spoken language

2012-2015

Code set available from the NISO w Needed as an independent variable in statistical models

to account for person-level demographic effects

msa Member MSA code

2012-2015

See United States Census Bureau Needed as an independent variable in statistical models

to account for person-level demographic effects

state Member state

2012-2015

Standard two character abbreviatio Needed as an independent variable in statistical models

to account for person-level demographic effects

zip Member zip code

2012-2015

Freely available in the public doma Needed to develop metrics for distance to provider

(access proxy)

fromdate From date

2012-2015

YYYY-MM-DD Needed to understand utilization patterns (e.g. whether

office visit was before or after hospitalization)

todate To date 2012-2015 YYYY-MM-DD See line 27

paid Total payment

2012-2015

Needed to track expenditures (primary dependent

variable)

copay Co-payment

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

coins Co-insurance

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

deduct Deductible

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

oop Patient pay amount

2012-2015

Required if deductible, co-pay, or c Needed to assess changes over time when comparing

Medicaid with Commercial or other other coverage

tob Type of bill

2012-2015

Needed to categorize claims by service setting and type

pos Place of service code

2012-2015

Needed to categorize claims by service setting and type

revcode Revenue code

2012-2015

See NUBC web site Needed to categorize claims by service setting and type

qty Quantity 2012-2015 Needed to analyze utilization

hcg HCG code

2012-2015

Needed to categorize claims by service setting and type

dx1 Principal diagnosis

2012-2015

See current ICD documentation fro Needed for episode grouper, as well as identification of

specific patient populations and co-morbidities. For

example, patients with mental health conditions are a

focus of our study and ICD-9 codes allow us to create

that cohort as well as to stratify by all mental illness and

serious mental illness. ICD-9 Codes are also necessary

for quality measures (including AHRQ Prevention Quality

Indicators) that are part of the study

dx2 Diagnosis 2

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx3 Diagnosis 3

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx4 Diagnosis 4

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx5 Diagnosis 5

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx6 Diagnosis 6

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx7 Diagnosis 7

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx8 Diagnosis 8

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

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Data Element Name Years Requested Filters Applied Justification Notes

dx9 Diagnosis 9

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx10 Diagnosis 10

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx11 Diagnosis 11

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx12 Diagnosis 12

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx13 Diagnosis 13

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

poa1 POA code 1

2012-2015

Needed for quality measures (e.g., AHRQ Prevention

Quality Indicators)

poa2 POA code 2

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa3 POA code 3

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa4 POA code 4

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa5 POA code 5

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa6 POA code 6

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa7 POA code 7

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa8 POA code 8

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa9 POA code 9

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa10 POA code 10

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa11 POA code 11

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa12 POA code 12

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa13 POA code 13

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

px1 Principal inpt procedure

2012-2015

See current ICD documentation fro Needed for quality measures (e.g., AHRQ Prevention

Quality Indicators)

px2 Procedure 2

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px3 Procedure 3

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

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Data Element Name Years Requested Filters Applied Justification Notes

px4 Procedure 4

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px5 Procedure 5

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px6 Procedure 6

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px7 Procedure 7

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px8 Procedure 8

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px9 Procedure 9

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px10 Procedure 10

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px11 Procedure 11

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px12 Procedure 12

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px13 Procedure 13

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

proccode CPT or HCPCS procedure code

2012-2015

See CMS web site for HCPCS cod Needed to identify primary care provider visits,

emergency department visits, and to separate claims by

Berenson-Eggers Type of Service (BETOS) codes)

mod1 Prodcure code modifier 1

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod2 Prodcure code modifier 2

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod3 Prodcure code modifier 3

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod4 Prodcure code modifier 4

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

dstatus Discharge status

2012-2015

Needed to determine where patients are discharged

(home, transfer, died)

los Length of stay

2012-2015

Needed to analyze utilization measure (dependent

variable)

msdrg MS-DRG

2012-2015

See current MS-DRG documentati Needed to analyze utilization measure (dependent

variable)

attid Attending provider ID

2012-2015

Needed to compare utlization/access across patients and

payer groups

spec Attending provider specialty

2012-2015

See provider taxonomy from NUCC Needed to compare utlization/access across patients and

payer groups

billid Billing provider ID

2012-2015

Needed to compare utlization/access across patients and

payer groups

entity Billing provider entity name

2012-2015

Needed to compare utlization/access across patients and

payer groups

icdver ICD version

2012-2015

The U.S. transitioned from ICD-9 to ICD-10 codes in

October 2015. This element is needed to identify

diagnosis and procedure codes under the new system.

Year Calendar year 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Payer ID Payer ID

2012-2015

Unique identifier for each payer that submits to APAC; in

combination with Carrier Name, needed to identify payers

with data issues

Bill_prov_lname_fac_cw Hospital Facility ID 2012-2015 Needed to analyze hospital-related outcomes

ADM_DATE/MC018 Admission date 2012-2015 Needed to analyze hospital-related outcomes

DIS_DATE/MC070 Discharge date 2012-2015 Needed to analyze hospital-related outcomes

MC204 Admission source 2012-2015 Needed to analyze hospital-related outcomes

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Data Element Name Years Requested Filters Applied Justification Notes

Carrier name Carrier name

2012-2015

Name of health insurance carrier associated with Payer

ID (a Payer-ID-to-carrier-name crosswalk may be

provided); in combination with Carrier Name, needed to

identify payers with data issues

2012-2015

All Pharmacy 2012-2015

clmid Claim ID 2012-2015 Needed to de-duplicate claim lines

line Claim line 2012-2015 Needed to de-duplicate claim lines

clmstatus Claim status 2012-2015 Needed to de-duplicate claim lines

cob COB status 2012-2015 Y/N flag

Needed to adjust for individuals with coverage from

multiple plans

paytype Payer type 2012-2015

Needed to provide additional granularity on differences in

patient populations and utilization across payers

prod Product code 2012-2015

Needed for analysis separating individuals covered under

HMO plans vs. individuals covered in PPO plans

payer APAC Payer 2012-2015 Needed to account for different payment rates

medflag Medical coverage flag 2012-2015 Y/N flag

Needed to identify individuals with medical coverage

only, rx coverage only, or both (e.g., to exclude

individuals with medical coverage only in analyses of total

cost)

rxflag Pharmacy coverage flag 2012-2015 Y/N flag

See line 13; allows for inclusion/exclusion criteria (e.g.,

individuals without rx coverage could be included in

analyses of hospitalizations in order to improve power but

excluded from analyses of total cost due to missing data)

pebb PEBB flag 2012-2015 0/1 flag

Plan type vairable needed to construct comparison

groups

oebb OEBB flag 2012-2015 0/1 flag

Plan type vairable needed to construct comparison

groups

patid Encrypted patient ID 2012-2015 Needed to de-duplicate claim lines (key field)

personkey Unique person identifier 2012-2015 Needed to de-duplicate claim lines (key field)

gender Gender 2012-2015 F, M, or U

Needed as an independent variable in statistical models

to account for person-level demographic effects

yob Birth year 2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

race Race 2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

ethn Ethnicity 2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

lang Primary spoken language 2012-2015 Code set available from the NISO w

Needed as an independent variable in statistical models

to account for person-level demographic effects

msa Member MSA code 2012-2015 See United States Census Bureau

Needed as an independent variable in statistical models

to account for person-level demographic effects

state Member state 2012-2015 Standard two character abbreviatio

Needed as an independent variable in statistical models

to account for person-level demographic effects

zip Member zip code 2012-2015 Freely available in the public doma

Used to develop metrics for distance to provider (access

proxy)

paid Total payment 2012-2015

Needed to track expenditures (primary dependent

variable)

copay Co-payment 2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

coins Co-insurance 2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

deduct Deductible 2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

oop Patient pay amount 2012-2015 Required if deductible, co-pay, or c

Needed to assess changes over time when comparing

Medicaid with Commercial or other other coverage

tob Type of bill 2012-2015

Needed to categorize claims by service setting and type

pos Place of service code 2012-2015

Needed to categorize claims by service setting and type

hcg HCG code 2012-2015

Needed to categorize claims by service setting and type

filldate Fill date 2012-2015 YYYY-MM-DD

Needed to understand utilization patterns (e.g. whether a

prescription for drug X occurred after a diagnosis of Y)

ndc NDC 2012-2015 Link to the NDC database Needed to stratify by drug class and substance

rxclass NDC therapeutic class 2012-2015 Needed to stratify by drug class and substance

brand Brand status 2012-2015 Needed to stratify by drug class and substance

rxcompound Compound drug indicator 2012-2015 1=no; 2=yes Needed to stratify by drug class and substance

qtydisp Quantity dispensed 2012-2015 Needed as a utilization measure (dependent variable)

rxdays Days supply 2012-2015 Needed as a utilization measure (dependent variable)

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Data Element Name Years Requested Filters Applied Justification Notes

daw Dispense as written code 2012-2015 Needed to characterize prescribing practices

PROV_NPI Provider NPI 2012-2015 Needed to characterize prescribing practices

entity Pharmacy name 2012-2015

Needed to compare utlization/access across patients and

payer groups

Year Calendar year 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Payer ID Payer ID 2012-2015

Unique identifier for each payer that submits to APAC; in

combination with Carrier Name, needed to identify payers

with data issues

generic Generic drug name 2012-2015 Needed to analyze utilization among dual eligibles

provid Prescribing provider ID 2012-2015 Needed as a linkage variable

Carrier name Carrier name 2012-2015

Name of health insurance carrier associated with Payer

ID (a Payer-ID-to-carrier-name crosswalk may be

provided); in combination with Carrier Name, needed to

identify payers with data issues

2012-2015

Episodes of Care 2012-2015

clmid Claim ID 2012-2015 Needed to de-duplicate claim lines

line Claim line 2012-2015 Needed to de-duplicate claim lines

clmstatus Claim status 2012-2015 Needed to de-duplicate claim lines

cob COB status

2012-2015

Y/N flag Needed to adjust for individuals with coverage from

multiple plans

paytype Payer type

2012-2015

Needed to provide additional granularity on differences in

patient populations and utilization across payers

prod Product code

2012-2015

Needed for analysis separating individuals covered under

HMO plans vs. individuals covered in PPO plans

payer APAC Payer 2012-2015 Needed to account for different payment rates

medflag Medical coverage flag

2012-2015

Y/N flag Needed to identify individuals with medical coverage

only, rx coverage only, or both (e.g., to exclude

individuals with medical coverage only in analyses of total

cost)

rxflag Pharmacy coverage flag

2012-2015

Y/N flag See line 13; allows for inclusion/exclusion criteria (e.g.,

individuals without rx coverage could be included in

analyses of hospitalizations in order to improve power but

excluded from analyses of total cost due to missing data)

pebb PEBB flag

2012-2015

0/1 flag Plan type vairable needed to construct comparison

groups

oebb OEBB flag

2012-2015

0/1 flag Plan type vairable needed to construct comparison

groups

patid Encrypted patient ID 2012-2015 Needed to de-duplicate claim lines

personkey Unique person identifier 2012-2015 Needed to de-duplicate claim lines

gender Gender

2012-2015

F, M, or U Needed as an independent variable in statistical models

to account for person-level demographic effects

yob Birth year

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

race Race

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

ethn Ethnicity

2012-2015

Needed as an independent variable in statistical models

to account for person-level demographic effects

lang Primary spoken language

2012-2015

Code set available from the NISO w Needed as an independent variable in statistical models

to account for person-level demographic effects

msa Member MSA code

2012-2015

See United States Census Bureau Needed as an independent variable in statistical models

to account for person-level demographic effects

state Member state

2012-2015

Standard two character abbreviatio Needed as an independent variable in statistical models

to account for person-level demographic effects

zip Member zip code

2012-2015

Freely available in the public doma Used to develop metrics for distance to provider (access

proxy)

fromdate From date

2012-2015

YYYY-MM-DD Dates of service allow us to understand utilization

patterns (e.g. whether office visit was before or after

hospitalization)

todate To date 2012-2015 YYYY-MM-DD Same as above

paid Total payment

2012-2015

Needed to track expenditures (primary dependent

variable)

copay Co-payment

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

coins Co-insurance

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

deduct Deductible

2012-2015

Needed to provide granularity on patient out-of-hospital

expenses

oop Patient pay amount

2012-2015

Required if deductible, co-pay, or c Needed to assess changes over time when comparing

Medicaid with Commercial or other other coverage

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Data Element Name Years Requested Filters Applied Justification Notes

tob Type of bill

2012-2015

Needed to categorize claims by service setting and type

pos Place of service code

2012-2015

Needed to categorize claims by service setting and type

revcode Revenue code

2012-2015

See NUBC web site Needed to categorize claims by service setting and type

qty Quantity 2012-2015 Needed to analyze utilization

hcg HCG code

2012-2015

Needed to categorize claims by service setting and type

dx1 Principal diagnosis

2012-2015

See current ICD documentation fro Needed for episode grouper, as well as identification of

specific patient populations and co-morbidities. For

example, patients with mental health conditions are a

focus of our study and ICD-9 codes allow us to create

that cohort as well as to stratify by all mental illness and

serious mental illness. ICD-9 Codes are also necessary

for quality measures (including AHRQ Prevention Quality

Indicators) that are part of the study

dx2 Diagnosis 2

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx3 Diagnosis 3

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx4 Diagnosis 4

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx5 Diagnosis 5

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx6 Diagnosis 6

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx7 Diagnosis 7

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx8 Diagnosis 8

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx9 Diagnosis 9

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx10 Diagnosis 10

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx11 Diagnosis 11

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx12 Diagnosis 12

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

dx13 Diagnosis 13

2012-2015

See current ICD documentation fro See line 39; while not all diagnosis codes are populated

for every claim, codes from dx2 through dx13 improve

accuracy of episode grouper output where populated

poa1 POA code 1

2012-2015

Needed for quality measures (e.g., AHRQ Prevention

Quality Indicators)

poa2 POA code 2

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa3 POA code 3

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa4 POA code 4

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

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Data Element Name Years Requested Filters Applied Justification Notes

poa5 POA code 5

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa6 POA code 6

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa7 POA code 7

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa8 POA code 8

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa9 POA code 9

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa10 POA code 10

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa11 POA code 11

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa12 POA code 12

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

poa13 POA code 13

2012-2015

See line 52; while not all POA codes are populated for

every claim, codes from poa 2 through poa 13 are useful

for analyzing utilization and quality where populated

px1 Principal inpt procedure

2012-2015

See current ICD documentation fro Needed for quality measures (e.g., AHRQ Prevention

Quality Indicators)

px2 Procedure 2

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px3 Procedure 3

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px4 Procedure 4

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px5 Procedure 5

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px6 Procedure 6

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px7 Procedure 7

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px8 Procedure 8

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px9 Procedure 9

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px10 Procedure 10

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px11 Procedure 11

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

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Data Element Name Years Requested Filters Applied Justification Notes

px12 Procedure 12

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

px13 Procedure 13

2012-2015

See current ICD documentation fro See line 65; while not all procedure codes are populated

for every claim, codes from px2 through px13 are useful

for analyzing utilization and quality where populated

proccode CPT or HCPCS procedure code

2012-2015

See CMS web site for HCPCS cod Needed to identify primary care provider visits,

emergency department visits, and to separate claims by

Berenson-Eggers Type of Service (BETOS) codes)

mod1 Prodcure code modifier 1

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod2 Prodcure code modifier 2

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod3 Prodcure code modifier 3

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

mod4 Prodcure code modifier 4

2012-2015

See CMS web site for HCPCS cod See line 78; procedure code modifiers are needed to

analyze utilization and quality

megcode MEG code

2012-2015

Illness classification/episode classification needed to

stratify or conduct separate analyses (e.g., understanding

how CCO transformation affects cost of epidsodes of

hypertension w/o complication)

megdesc MEG description

2012-2015

See line 85; needed to provide clarity on type of episode,

which will be used to stratify/separate analyses

megbodysys MEG body system

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megstage MEG stage

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megtype MEG type of care description

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megcomplete MEG episode completion

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megnum MEG episode number

2012-2015

Needed as episode ID to link claims, analyze claims, and

compare costs across treatment episodes

megdays MEG episode duration in days

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megprorate MEG prorated episode count

2012-2015

Along with megcode and megbodysys, needed to carry

out analyses involving medical episode grouper

megoutlier MEG outlier indicator 2012-2015 Needed to exclude

meglow MEG low outlier indicator 2012-2015 Needed to exclude

meghigh MEG high outlier indicator 2012-2015 Needed to exclude

ndc NDC

2012-2015

Link to the NDC database National Drug Code needed to identify specific drugs

(e.g., publicly available crosswalks allow for identification

of all "mental health" drugs through NDC)

rxclass NDC therapeutic class

2012-2015

Therapeutic class needed to identify specific drug

classes (utilization measure)

qtydisp Quantity dispensed 2012-2015 Needed as an adherence/utilization measure

rxdays Days supply 2012-2015 Needed as an adherence/utilization measure

daw Dispense as written code 2012-2015 Needed as a utilization measure

dstatus Discharge status 2012-2015 Needed to identify source of patients discharges

los Length of stay 2012-2015 Needed as a utilization measure (dependent variable)

msdrg MS-DRG 2012-2015 See current MS-DRG documentati Needed as a utilization measure (dependent variable)

attid Attending provider ID

2012-2015

Needed to compare utlization/access across patients and

payer groups

spec Attending provider specialty

2012-2015

See provider taxonomy from NUCC Needed to compare utlization/access across patients and

payer groups

billid Billing provider ID

2012-2015

Needed to compare utlization/access across patients and

payer groups

entity Billing provider entity name

2012-2015

Needed to compare utlization/access across patients and

payer groups

icdver ICD version

2012-2015

The U.S. transitioned from ICD-9 to ICD-10 codes in

October 2015. This element is needed to identify

diagnosis and procedure codes under the new system.

Year Calendar year 2012-2015 Needed as an independent variable in statistical models to account for person-level demographic effects

Payer ID Payer ID

2012-2015

Unique identifier for each payer that submits to APAC; in

combination with Carrier Name, needed to identify payers

with data issues

Carrier name Carrier name

2012-2015

Name of health insurance carrier associated with Payer

ID (a Payer-ID-to-carrier-name crosswalk may be

provided); in combination with Carrier Name, needed to

identify payers with data issues

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Data Element Name Years Requested Filters Applied Justification Notes

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Mark each payer you are

requesting with "X".

Justify why each

payer requested is

necessary.

See Filters tab for

sample filters. Payer Type Payer notes

Payer Requested Justification Filters Applied Payer Notes

X Comparison between payers on access, costs All Payers All Payers includes Medicaid, Medicare Advantage, and Private Commercial Insurance (includes OEBB/PEBB).

Medicaid

REQUESTERS MAY NOT REQUEST MEDICAID DATA ONLY. For those that only want Medicaid data, APAC is not the

appropriate data source. Please contact [email protected] for further instruction.

Medicare Advantage

Private Commercial Insurance (includes OEBB/PEBB)

OEBB/PEBB Select if requesting OEBB/PEBB data only

Medicare FFS Medicare FFS data will only be given to projects in which OHA is funding and directing.

Payers

The following payers are available for request. You may request all payers, or one or more specific payer. Requesters must provide a justification for each payer requested.

Specify filters for each

element requested, if

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APPROVAL OF SUBMISSION

December 28, 2016 Dear Investigator:

On 12/28/2016, the IRB reviewed the following submission:

IRB ID: STUDY00015633 MOD or CR ID: CR00001566 Type of Review: Continuing Review

Title of Study: Examining the impact of health care reform on publicly funded family planning in Oregon

Principal Investigator: Maria Rodriguez Funding: Name: DHHS NIH Natl Inst of Child Hlth & Human

Dvlp, PPQ #: 1006583 IND, IDE, or HDE: None

Documents Reviewed: • Proposed Project Questionnaire (PPQ) • Protocol v1 • HIPAA Waiver of Authorization v1 • Data Collection Sheet v1

The IRB granted final approval on 12/28/2016. The study is approved until 12/27/2017.

Review Category: Expedited Category # 5

Copies of all approved documents are available in the study's Final Documents (far right column under the documents tab) list in the eIRB. Any additional documents that require an IRB signature (e.g. IIAs and IAAs) will be posted when signed. If this applies to your study, you will receive a notification when these additional signed documents are available.

Ongoing IRB submission requirements:

• Six to ten weeks before the expiration date, you are to submit a continuing review to request continuing approval.

• Any changes to the project must be submitted for IRB approval prior to implementation.

• Reportable New Information must be submitted per OHSU policy.

Version Date: 06/30/2016 Page 1 of 2

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• You must submit a continuing review to close the study when your research is completed.

Guidelines for Study Conduct

In conducting this study, you are required to follow the guidelines in the document entitled, "Roles and Responsibilities in the Conduct of Research and Administration of Sponsored Projects," as well as all other applicable OHSU IRB Policies and Procedures.

Requirements under HIPAA

If your study involves the collection, use, or disclosure of Protected Health Information (PHI), you must comply with all applicable requirements under HIPAA. See the HIPAA and Research website and the Information Privacy and Security website for more information.

IRB Compliance

The OHSU IRB (FWA00000161; IRB00000471) complies with 45 CFR Part 46, 21 CFR Parts 50 and 56, and other federal and Oregon laws and regulations, as applicable, as well as ICH-GCP codes 3.1-3.4, which outline Responsibilities, Composition, Functions, and Operations, Procedures, and Records of the IRB.

Sincerely,

The OHSU IRB Office

Version Date: 06/30/2016 Page 2 of 2